AZITHROMYCIN powder, for suspension

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)

Disponible desde:

RPK Pharmaceuticals, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)] [see Use in Specific Populations (8.4) and Clinical Studies (14.2)] Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or

Resumen del producto:

Product: 53002-2231 NDC: 53002-2231-1 15 mL in a BOTTLE, PLASTIC NDC: 53002-2231-2 30 mL in a BOTTLE, PLASTIC

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

AZITHROMYCIN- AZITHROMYCIN POWDER, FOR SUSPENSION
RPK PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZITHROMYCIN FOR ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR AZITHROMYCIN FOR
ORAL SUSPENSION.
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Cardiovascular Death (5.5) 11/2021
INDICATIONS AND USAGE
Azithromycin for oral suspension USP is a macrolide antibacterial drug
indicated for mild to moderate
infections caused by designated, susceptible bacteria:
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Limitation of Use:
Azithromycin should not be used in patients with pneumonia who are
judged to be inappropriate for oral
therapy because of moderate to severe illness or risk factors. (1.3)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of azithromycin and
other antibacterial drugs, azithromycin should be used only to treat
infections that are proven or strongly
suspected to be caused by susceptible bacteria. (1.4)
DOSAGE AND ADMINISTRATION
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INFECTION
RECOMMENDED DOSE/DURATION OF THERAPY
Acute otitis media
(6 months of age and older)
30 mg/kg as a single dose or 10 mg/kg once daily for 3
days or 10 mg/kg as a single dose on Day 1 followed by 5
mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis
(6 months of age and older)
10 mg/kg once daily for 3 days.
Acute bacterial exacerbations of chronic bronchitis in adults (1.1)
Acute bacterial sinusitis in adults (1.1)
Uncomplicated skin and skin structure infections in adults (1.1)
Urethritis and cervicitis in adults (1.1)
Genital ulcer disease in men (1.1)
Acute otitis media in pediatric patients (6 months of age and older)
(1.2)
Community-acquired pneumonia in adults and pediatric patients (6
months of age and older) (1.1,
1.2)
Pharyngitis/tonsillitis in adults and pediatric patients (2 years of
age and older) (1.1, 1.2)
ADULT PATIENTS (2.1)
INFECTION
RECOMMENDED DOSE/DURATION
OF THERAPY
Com